TFF Pharmaceuticals, Inc.

Good morning, ladies and gentlemen, and welcome to the TFF Pharmaceuticals Second Quarter 2023 Corporate Update and Earnings Conference Call. As a reminder, this conference is being recorded. I'll now turn the call over to your host, Corey Davis of LifeSci Advisors. You may begin your conference.

Thank you, operator. Hello, everyone, and welcome to TFF Pharmaceuticals Second Quarter 2023 Corporate Update and Earnings Conference Call. With me on the line this afternoon are Dr. Harlan Weissman, Chief Executive Officer of TFF Pharmaceuticals, Dr. Zamaneh Mekak, Chief Medical Officer, and Kirk Coleman, Chief Financial Officer. Before we get started, I would like to remind everyone that this call will contain forward-looking statements, including without limitation statements about the anticipated timing of achievement of clinical milestones, the potential to see positive effects in our phase two studies, the number of treated patients necessary to make our decisions in regards to moving to phase three studies, the market opportunity for our product candidates, and the expected timeframe for funding operations with cash and cash equivalents. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in all of our findings with the U.S. Securities and Exchange Commission. including the risk factor section of our 2022 annual report on Form 10-K filed with the SEC. And now it's my pleasure to turn the call over to Dr. Harlan Weissman. Harlan? Thank you, John.

And good morning, everyone. And thank you for joining us for our second quarter 2023 corporate update and earnings conference call. On today's call, I'm going to review the significant progress that we've made over the first half of 2023, and then provide an outlook on what we expect to achieve for the remainder of the year. Following my remarks, our Chief Medical Officer, Dr. Zalmanay Mekak, will provide an update on TFS clinical stage programs. Our Chief Financial Officer, Kirk Coleman, We'll then review our financial results for the second quarter. We'll then open up the call for Q&A. In early February, soon after my appointment as TFS permanent CEO, we held an investor call to review our corporate strategy and outline our objectives for 2023. On that call, we expressed our commitment to grow shareholder value by prioritizing the advancement of our clinical stage assets, TFF 4E and TFF TAC. We also expressed a desire to remain opportunistic with respect to signing new partnerships that showed the potential to create long-term value while also minimizing internal costs to our company. It's been nearly six months since that call, and I can say that I'm proud of the company's progress on both fronts. Under Zaminet's leadership, our clinical development team has made considerable progress across a number of key areas to help build physician and patient awareness of TFF-4E and TFF-TAC. Based on the continued success of these efforts, we anticipate reaching key clinical milestones by year end. each of which could serve as a major catalyst for our company. In a moment, the nominee will provide greater details on each of these rare disease programs. We will also have sufficient capital to reach these milestones. As announced earlier this morning, TFF raised additional capital through an equity financing. Importantly, no warrants were issued to investors in this transaction. Considering the ongoing challenges in the capital markets, our ability to close this financing while minimizing dilution to our existing shareholders, in my view, reflects a growing recognition of the attractive risk-reward of our two clinical programs. In contrast to programs involving new chemical entities, TFF-4E and TFF-TAC couple significant innovation with reduced clinical development risk. The innovation is driven, of course, by our thin-film freezing technology that enables efficacious levels of boriconazole and tacrolimus to be delivered directly into the lungs. Through this improved delivery, we expect to see strong efficacy but with lower toxicity and drug-drug interactions compared to systemic delivery. Positions have told us that they would welcome these types of solutions to improve overall care in these highly vulnerable patient populations. We also believe each program bears significantly less clinical risk compared to other development stage programs. By improving the delivery of two well-established first-line FDA-approved drugs, we expect to see positive treatment effects for most of the patients enrolling in our ongoing phase two trials. For this reason, I believe TFF represents a compelling opportunity for investors who seek an optimal balance of innovation coupled with lower overall clinical development risk. Developing new therapies like TFF Worry and TFF TAC that can efficiently deliver an effective drug while lowering systemic toxicities is likely to have a significant positive impact on overall patient health, clinical outcomes, and health economics. Given the size of the patient population, the level of unmet need, the economic burden of each disease, and the anticipated impact of TFF-Vory and TFF-TAC on clinical outcomes, We believe each product represents a $1 billion plus market opportunity. While advancing our pipeline remains our primary strategic objective, I'm also pleased to note that business development at TFF remains quite active. We announced three separate government collaborations during the quarter, which provide third-party validation of the value of our thin-film freezing technology. In May, we signed a cooperative research and development agreement, or CRADA, with the National Institute of Environmental Health Sciences, part of the National Institutes of Health, to develop dry powder formulations of hyaluronan to prevent and treat respiratory diseases. NIEHS and TFF will evaluate the pharmacokinetics and therapeutic efficacy of TFF hyaluronan formulations using in vitro and in vivo models of select respiratory diseases, with a primary focus on chronic obstructive pulmonary disease, or COPD, and viral respiratory diseases caused by SARS-CoV-2, influenza virus, and or respiratory syncytial virus, or RSV. Also in May, we signed a contract extension with Leidos that provides additional funding to advance next generation personalized protective biosystems under the personalized protective biosystems program managed by the Defense Advanced Research Projects Agency, more commonly referred to as DARPA. The goal of the program is to develop lightweight materials using thin-film freezing technology that protects military and healthcare personnel from exposure to chemical and biological threats. In June, we announced an agreement with the National Institute of Allergy and Infectious Diseases, also part of the National Institutes of Health, that awarded TFF Pharmaceuticals a direct to phase two small business innovation research or SBIR grant of approximately $3 million to continue development of a shelf-stable universal influenza mucosal vaccine using the company's thin-film freezing technology. The aim of this program is to develop a vaccine that is at least 75% effective against symptomatic influenza virus infection. Importantly, these agreements are largely funded by our partners. and provide an important source of external validation for our technology. I'd now like to turn the call over to Dr. Zamaneh Mekak to discuss the TFF-4E and TFF-TAC clinical programs.